Efficacy of a novel SARS-CoV-2 detection kit without RNA extraction and purification

Fukumoto, Tatsuya; Iwasaki, Sumio; Fujisawa, Shinichi; Hayasaka, Kasumi; Sato, Kaori; Oguri, Satoshi; Taki, Keisuke; Nakakubo, Sho; Kamada, Keisuke; Yamashita, Yu; Konno, Satoshi; Nishida, Mutsumi; Sugita, Junichi; Teshima, Takanori

Rapid detection of SARS-CoV-2 is critical for the diagnosis of coronavirus disease 2019 (COVID-19) and preventing the spread of the virus. A novel “2019 Novel Coronavirus Detection Kit (nCoV-DK)” halves detection time by eliminating the steps of RNA extraction and purification. We evaluated concordance between the nCoV-DK and direct PCR. The virus was detected in 53/71 fresh samples by the direct method and 55/71 corresponding frozen samples by the nCoV-DK. The overall concordance rate of the virus detection between the two methods was 94.4% (95% CI, 86.2-98.4). Concordance rates were 95.2% (95% CI, 83.8-99.4), 95.5% (95% CI, 77.2-99.9), 85.7% (95% CI, 42.1-99.6) in nasopharyngeal swab, saliva, and sputum samples, respectively. These results indicate that the nCoV-DK effectively detects SARS-CoV-2 in all types of the samples including saliva, while reducing time required for detection, labor, and risk of human error.